US8231896B2 - Non-gelatin soft capsule system - Google Patents

Non-gelatin soft capsule system Download PDF

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Publication number
US8231896B2
US8231896B2 US10/984,205 US98420504A US8231896B2 US 8231896 B2 US8231896 B2 US 8231896B2 US 98420504 A US98420504 A US 98420504A US 8231896 B2 US8231896 B2 US 8231896B2
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US
United States
Prior art keywords
starch
gelatin
active ingredient
soft capsule
capsule system
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active, expires
Application number
US10/984,205
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English (en)
Other versions
US20060099246A1 (en
Inventor
Keith E. Tanner
Rickey S. Shelley
Norman S. Stroud
Elizabeth Youngblood
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Catalent Pharma Solutions LLC
RP Scherer Technologies LLC
Catalent Pharma Solutions Inc
Catalent USA Woodstock Inc
Catalent USA Paintball Inc
Catalent USA Packaging LLC
Original Assignee
RP Scherer Technologies LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US10/984,205 priority Critical patent/US8231896B2/en
Application filed by RP Scherer Technologies LLC filed Critical RP Scherer Technologies LLC
Priority to AT05823349T priority patent/ATE536866T1/de
Priority to MX2007005403A priority patent/MX2007005403A/es
Priority to HK07110089.4A priority patent/HK1108363B/en
Priority to PCT/US2005/038532 priority patent/WO2006052452A1/en
Priority to PT05823349T priority patent/PT1809261E/pt
Priority to SI200531747T priority patent/SI1809261T1/sl
Priority to EP05823349A priority patent/EP1809261B1/de
Priority to CA2585721A priority patent/CA2585721C/en
Priority to JP2007540346A priority patent/JP5192816B2/ja
Priority to DK05823349.5T priority patent/DK1809261T3/da
Priority to BRPI0517674A priority patent/BRPI0517674B8/pt
Priority to PL05823349T priority patent/PL1809261T3/pl
Priority to EP10194764.6A priority patent/EP2289496B1/de
Priority to AU2005305232A priority patent/AU2005305232B2/en
Priority to ES10194764.6T priority patent/ES2603225T3/es
Priority to ES05823349T priority patent/ES2379970T3/es
Assigned to R.P. SCHERER TECHNOLOGIES, INC. reassignment R.P. SCHERER TECHNOLOGIES, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SHELLEY, RICKEY S., STROUD, NORMAN S., TANNER, KEITH E., YOUNGBLOOD, ELIZABETH
Priority to PE2005001306A priority patent/PE20061136A1/es
Priority to ARP050104668A priority patent/AR051237A1/es
Priority to UY29200A priority patent/UY29200A1/es
Priority to TW094139199A priority patent/TWI405592B/zh
Publication of US20060099246A1 publication Critical patent/US20060099246A1/en
Assigned to MORGAN STANLEY SENIOR FUNDING, INC. reassignment MORGAN STANLEY SENIOR FUNDING, INC. SECURITY AGREEMENT Assignors: CARDINAL HEALTH 400, INC., CARDINAL HEALTH 406, LLC, CARDINAL HEALTH 409, INC., CARDINAL HEALTH 421, INC., CARDINAL HEALTH PTS, LLC, GLACIER CORPORATION, PTS ACQUISITION CORP., PTS INTERMEDIATE HOLDINGS LLC, R.P. SCHERER TECHNOLOGIES, INC.
Assigned to CATALENT PHARMA SOLUTIONS, INC., CATALENT PHARMA SOLUTIONS, LLC, CATALENT USA PACKAGING, LLC, CATALENT USA PAINTBALL, INC., CATALENT USA WOODSTOCK, INC. reassignment CATALENT PHARMA SOLUTIONS, INC. CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: CARDINAL HEALTH 400, INC., CARDINAL HEALTH 406, LLC, CARDINAL HEALTH 409, INC., CARDINAL HEALTH 421, INC., CARDINAL HEALTH PTS, LLC
Priority to CY20121100264T priority patent/CY1112518T1/el
Assigned to R.P. SCHERER TECHNOLOGIES, LLC reassignment R.P. SCHERER TECHNOLOGIES, LLC CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: R.P. SCHERER TECHNOLOGIES, INC.
Priority to US13/543,244 priority patent/US8377470B2/en
Publication of US8231896B2 publication Critical patent/US8231896B2/en
Application granted granted Critical
Assigned to JPMORGAN CHASE BANK, N.A. reassignment JPMORGAN CHASE BANK, N.A. NOTICE OF SUCCESSION OF AGENCY Assignors: MORGAN STANLEY SENIOR FUNDING, INC.
Assigned to ARES CAPITAL CORPORATION, AS COLLATERAL AGENT reassignment ARES CAPITAL CORPORATION, AS COLLATERAL AGENT SECURITY INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CATALENT CTS (KANSAS CITY), LLC, CATALENT GREENVILLE, INC., CATALENT MARYLAND, INC., CATALENT MICRON TECHNOLOGIES, INC., CATALENT PHARMA SOLUTIONS, INC., CATALENT PHARMA SOLUTIONS, LLC, CATALENT SAN DIEGO, INC., CATALENT USA PACKAGING, LLC, CATALENT WELLNESS NEW JERSEY, LLC, CATALENT WELLNESS VIRGINIA, LLC, CATALENT WELLNESS, LLC, R.P. SCHERER TECHNOLOGIES, LLC, REDWOOD BIOSCIENCE, INC.
Assigned to R.P. SCHERER TECHNOLOGIES, LLC, R.P. SCHERER TECHNOLOGIES, INC., CATALENT PHARMA SOLUTIONS, LLC, R.P. SCHERER CORPORATION reassignment R.P. SCHERER TECHNOLOGIES, LLC RELEASE OF SECURITY INTEREST IN PATENT COLLATERAL (019323/0302) Assignors: JPMORGAN CHASE BANK, N.A.
Active legal-status Critical Current
Adjusted expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material

Definitions

  • Rotary die manufacture of soft gelatin capsules is disclosed in detail in The Theory and Practice of Industrial Pharmacy (Lachman, Lieberman and Kanig, Editors), 3rd Edition, published by Lea & Febiger. A good description of gelatin encapsulation techniques can also be found in WO 98/42294 (PCT/GB98/00830).
  • the pH of the fill liquid should not be below 2.5 or above 7.5. At pH's below 2.5, the gelatin is hydrolyzed causing leaking, whereas at pH's greater than 7.5, the gelatin can also be hydrolyzed.
  • emulsions of oil/water or water/oil are not suitable for softgel encapsulation because the emulsions eventually break down, releasing water which dissolves the gelatin shell.
  • the solvent or carrier in some cases must have sufficient solvating power to dissolve a large amount of the pharmaceutical agent to produce a highly concentrated solution, and yet not hydrolyze, dissolve, or discolor the gelatin shell.
  • the films were cast and allowed to form and set. A rectangular section of each film was cut, removed, and placed onto a wire test tube rack. Depressions were allowed to form in sections of each film. These depressions were then filled with concentrated alkali in the form of a pellet of potassium hydroxide. The test rig was then placed in and maintained in an oven at 30° C. and 95% relative humidity (RH.). Interaction between the alkali and the film was monitored at regular intervals.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
US10/984,205 2004-11-08 2004-11-08 Non-gelatin soft capsule system Active 2028-07-09 US8231896B2 (en)

Priority Applications (23)

Application Number Priority Date Filing Date Title
US10/984,205 US8231896B2 (en) 2004-11-08 2004-11-08 Non-gelatin soft capsule system
BRPI0517674A BRPI0517674B8 (pt) 2004-11-08 2005-10-26 sistema de cápsula mole de não-gelatina contendo amido modificado e carragenina com solução de enchimento de natureza básica
HK07110089.4A HK1108363B (en) 2004-11-08 2005-10-26 Non-gelatin soft capsule system
PCT/US2005/038532 WO2006052452A1 (en) 2004-11-08 2005-10-26 Non-gelatin soft capsule system
PT05823349T PT1809261E (pt) 2004-11-08 2005-10-26 Sistema de cápsula mole não gelatinosa
SI200531747T SI1809261T1 (sl) 2004-11-08 2005-10-26 Sistem mehke neĹľelatinaste kapsule
EP05823349A EP1809261B1 (de) 2004-11-08 2005-10-26 Gelatinefreies weichkapselsystem
CA2585721A CA2585721C (en) 2004-11-08 2005-10-26 Non-gelatin soft capsule system
JP2007540346A JP5192816B2 (ja) 2004-11-08 2005-10-26 非ゼラチン軟質カプセルシステム
MX2007005403A MX2007005403A (es) 2004-11-08 2005-10-26 Sistema de capsulas blandas que no contienen gelatina.
DK05823349.5T DK1809261T3 (da) 2004-11-08 2005-10-26 Gelatinefrit system med bløde kapsler
PL05823349T PL1809261T3 (pl) 2004-11-08 2005-10-26 Układ nieżelatynowej, miękkiej kapsułki
EP10194764.6A EP2289496B1 (de) 2004-11-08 2005-10-26 Gelatinefreies Weichkapselsystem
AU2005305232A AU2005305232B2 (en) 2004-11-08 2005-10-26 Non-gelatin soft capsule system
ES10194764.6T ES2603225T3 (es) 2004-11-08 2005-10-26 Sistema de cápsulas blandas sin gelatina
ES05823349T ES2379970T3 (es) 2004-11-08 2005-10-26 Sistema de cápsula blanda sin gelatina
AT05823349T ATE536866T1 (de) 2004-11-08 2005-10-26 Gelatinefreies weichkapselsystem
PE2005001306A PE20061136A1 (es) 2004-11-08 2005-11-08 Sistema de capsulas blandas que no son de gelatina
TW094139199A TWI405592B (zh) 2004-11-08 2005-11-08 非明膠軟膠囊系統
ARP050104668A AR051237A1 (es) 2004-11-08 2005-11-08 Sistema de capsula blanda sin gelatina
UY29200A UY29200A1 (es) 2004-11-08 2005-11-08 Sistema de cápsula blanda sin gelatina
CY20121100264T CY1112518T1 (el) 2004-11-08 2012-03-14 Συστημα μη ζελατινωδους μαλακου καψακιου
US13/543,244 US8377470B2 (en) 2004-11-08 2012-07-06 Non-gelatin soft capsule system

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US10/984,205 US8231896B2 (en) 2004-11-08 2004-11-08 Non-gelatin soft capsule system

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US13/543,244 Division US8377470B2 (en) 2004-11-08 2012-07-06 Non-gelatin soft capsule system

Publications (2)

Publication Number Publication Date
US20060099246A1 US20060099246A1 (en) 2006-05-11
US8231896B2 true US8231896B2 (en) 2012-07-31

Family

ID=36316590

Family Applications (2)

Application Number Title Priority Date Filing Date
US10/984,205 Active 2028-07-09 US8231896B2 (en) 2004-11-08 2004-11-08 Non-gelatin soft capsule system
US13/543,244 Expired - Lifetime US8377470B2 (en) 2004-11-08 2012-07-06 Non-gelatin soft capsule system

Family Applications After (1)

Application Number Title Priority Date Filing Date
US13/543,244 Expired - Lifetime US8377470B2 (en) 2004-11-08 2012-07-06 Non-gelatin soft capsule system

Country Status (19)

Country Link
US (2) US8231896B2 (de)
EP (2) EP1809261B1 (de)
JP (1) JP5192816B2 (de)
AR (1) AR051237A1 (de)
AT (1) ATE536866T1 (de)
AU (1) AU2005305232B2 (de)
BR (1) BRPI0517674B8 (de)
CA (1) CA2585721C (de)
CY (1) CY1112518T1 (de)
DK (1) DK1809261T3 (de)
ES (2) ES2379970T3 (de)
MX (1) MX2007005403A (de)
PE (1) PE20061136A1 (de)
PL (1) PL1809261T3 (de)
PT (1) PT1809261E (de)
SI (1) SI1809261T1 (de)
TW (1) TWI405592B (de)
UY (1) UY29200A1 (de)
WO (1) WO2006052452A1 (de)

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US9408858B2 (en) 2007-04-25 2016-08-09 Opko Renal, Llc Method for treating secondary hyperparathyroidism in CKD
US20170143644A1 (en) * 2015-11-23 2017-05-25 Undoo, LLC Composition of Olivetol and Method of Use to Reduce or Inhibit the Effects of Tetrahydrocannabinol in the Human Body
US20170340572A1 (en) * 2016-05-25 2017-11-30 TSI Group Ltd. Stabilization of beta-hydroxyisovaleric acid formulations in soft gel capsules
US9861644B2 (en) 2013-03-15 2018-01-09 Opko Ireland Global Holdings, Ltd. Stabilized modified release vitamin D formulation and method of administering same
US9943530B2 (en) 2006-02-03 2018-04-17 Opko Renal, Llc Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
WO2018161054A1 (en) 2017-03-03 2018-09-07 Rgenix, Inc. Formulations with improved stability
US10220047B2 (en) 2014-08-07 2019-03-05 Opko Ireland Global Holdings, Ltd. Adjunctive therapy with 25-hydroxyvitamin D and articles therefor
US10302660B2 (en) 2008-04-02 2019-05-28 Opko Renal, Llc Methods useful for vitamin D deficiency and related disorders
US10668089B2 (en) 2006-06-21 2020-06-02 Opko Ireland Global Holdings, Ltd. Method of treating and preventing secondary hyperparathyroidism
US10711119B2 (en) 2018-01-10 2020-07-14 Cp Kelco Aps Carrageenan-based compositions for films and capsules
WO2021016305A1 (en) * 2019-07-23 2021-01-28 R.P. Scherer Technologies, Llc Softshell capsule formulations, and methods of preparation and use thereof
US11173168B2 (en) 2016-03-28 2021-11-16 Eirgen Pharma Ltd. Methods of treating vitamin D insufficiency in chronic kidney disease
US11672809B2 (en) 2010-03-29 2023-06-13 Eirgen Pharma Ltd. Methods and compositions for reducing parathyroid levels
US11752158B2 (en) 2007-04-25 2023-09-12 Eirgen Pharma Ltd. Method of treating vitamin D insufficiency and deficiency
US11801253B2 (en) 2007-04-25 2023-10-31 Opko Renal, Llc Method of safely and effectively treating and preventing secondary hyperparathyroidism in chronic kidney disease

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US8802139B2 (en) 2003-06-26 2014-08-12 Intellipharmaceutics Corp. Proton pump-inhibitor-containing capsules which comprise subunits differently structured for a delayed release of the active ingredient
US8394409B2 (en) * 2004-07-01 2013-03-12 Intellipharmaceutics Corp. Controlled extended drug release technology
US10624858B2 (en) 2004-08-23 2020-04-21 Intellipharmaceutics Corp Controlled release composition using transition coating, and method of preparing same
US20070053868A1 (en) * 2005-03-08 2007-03-08 Banner Pharmacaps, Inc. Solvent system for enhancing the solubility of pharmaceutical agents
US10064828B1 (en) 2005-12-23 2018-09-04 Intellipharmaceutics Corp. Pulsed extended-pulsed and extended-pulsed pulsed drug delivery systems
CN104825397A (zh) * 2006-04-03 2015-08-12 伊萨·奥迪迪 含有机溶胶涂层的受控释放递送物件
US10960077B2 (en) 2006-05-12 2021-03-30 Intellipharmaceutics Corp. Abuse and alcohol resistant drug composition
JP5021263B2 (ja) * 2006-10-02 2012-09-05 中日本カプセル 株式会社 皮膜用組成物
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JP5696149B2 (ja) 2009-09-10 2015-04-08 エフ エム シー コーポレーションＦｍｃ Ｃｏｒｐｏｒａｔｉｏｎ シームレスなアルギン酸塩カプセル
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KR101411364B1 (ko) * 2012-03-16 2014-06-30 주식회사 서흥 전분을 주기재로 사용한 연질 캡슐 피막 조성물
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JP5597770B2 (ja) * 2011-04-20 2014-10-01 サフン カプセル カンパニー， リミテッド 崩解度及び被膜硬度を改善した非動物性軟質カプセル被膜組成物
US9980916B2 (en) 2013-03-15 2018-05-29 Patheon Softgels, Inc. Non-gelatin enteric soft capsules
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JP5769760B2 (ja) * 2013-06-25 2015-08-26 アール．ピー． シェーラー テクノロジーズ エルエルシー ソフトカプセル用シェル形成組成物及びソフトカプセル
US20150010622A1 (en) * 2013-07-03 2015-01-08 R.P. Scherer Technologies, Llc Capsule formulation comprising fexofenadine
WO2015059864A1 (ja) * 2013-10-25 2015-04-30 コニカミノルタ株式会社 粒子状肥料およびその製造方法
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